Supportive Treatment of Severe Heart Failure by Renal Denervation

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02638324

Acronym

Heart-RND

Enrollment

Registered

2015-12-23

Start date

2014-12-01

Completion date

2019-01-30

Last updated

2021-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

Renal nervous denervation

Brief summary

The overactivity of sympathetic nervous system is worsening the hemodynamic state of heart failure patients. The present study is planned to reduce the sympathetic tone in patients with severe heart failure by renal nervous denervation.

Detailed description

The patient population consists of heart failure patients who are not responding properly to medication and biventricular pacing therapy. The inappropriate response to these therapies is evaluated by patient history (NYHA III-IV), echocardiography (EF \< 45%), 6-minute walking test (\<440m) and measurements of P-ProBNP. The patients who fulfill the inclusion criteria will undergo renal nervous denervation. The patients will be followed up with the same methods as they were recruited to the study (by patient history (NYHA III-IV), echocardiography (EF \< 45%), 6-minute walking test (\<440m) and measurements of P-ProBNP). The overall time of follow-up will be 24 months. The patients are randomised according to the waiting list principle in a manner to 1:1. The waiting time will be 6 months.

Interventions

PROCEDURERenal nervous denervation

The heart failure patients will undergo renal nervous denervation if they have not properly responded to medication and biventricular pacing therapy.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* NYHA III-IV * ejection fraction \<45 % * 6-minute walking test under 440m

Exclusion criteria

* Unstable hemodynamic state * uncooperation

Design outcomes

Primary

Measure	Time frame	Description
6-minute walking test	24 months	Composite outcome measure

Secondary

Measure	Time frame	Description
Patient history	24 months	Composite outcome measure
Cardiac echocardiography	24 months	Composite outcome measure
P-proBNP	24 months	Composite outcome measure

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026